As of August 5th, when you conduct a search for “medical apps” in Apple’s App Store, over 10,000 results are shown for the iPhone, illustrating the increasing demand for mobile medical apps by today’s consumer. As momentum grows for these apps, it’s inevitable that scrutiny isn’t far behind, whether from consumers or the government.
As such, it comes as no surprise that last month the FDA announced that it is seeking public comments on a proposal concerning the regulation of mobile medical apps. Specifically, the FDA has targeted those mobile apps which are used “as an accessory to a regulated medical device” or “transforms a mobile platform into a regulated medical device”. Just a few years ago, this announcement wouldn’t have been a blip on anyone’s radar, but times have changed. Some estimate that over 81% of doctors have a smartphone[1], which means that regulation could impact many users.
As such, it begs the question “Is regulation really necessary?” Proponents of these apps will cite convenience, particularly while on the go. There’s no better example of this than emergency room doctors, of which 40% are users of mobile devices and content[2]. Opponents will cite concerns over patient safety, even though the FDA has not received any reports of adverse health outcomes connected with these apps[3].
No matter which side of the fence you are on, the decisions to be made concerning this topic will affect us all one way or another.
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[1] Doctors driving IT development with their mobile technology choices by Pamela Lewis Dolan
[2] Emergency room doctors number one consumers of mobile, pathologists last, per report of physician mobile use by Iltifat Husain, MD
[3] mHealth Care Crisis by Torie Bosch
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